Impact of Insulin Glargine compared to Insulin Detemir in combination with Metformin (BOT) on prandial beta cell function and overall metabolic control in type 2 diabetic patients with insufficient metabolic control during OAD Treatment - Insulin glargine and prandial beta cell function

• Conditions: Diabetes mellitus Type 2; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-006109-26-DE
• Lead Sponsor: Institut für Klinische Forschung und Entwicklung (ikfe) GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-16
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Type 2 Diabetes mellitus according to the ADA criteria
2. HbA1c between 6.5 % and 8.5 %
3. Monotherapy with metformin or combined with sulfonylurea in a stable dosage within the last 3 months
4. Age between 40 and 75 years
5. Fasting intact proinsulin level > 7 pmol/L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Type 1 Diabetes mellitus
2. Pre-Treatment with insulin within the last 3 months prior to screening
3. Pre-Treatment with PPARy-agonists (glitazones) within the last 3 months prior to screening
4. Major micro- or macrovascular complications as judged by the investigator
5. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
6. BMI > 45 kg/m²
7. Hypokalemia (K < 3.5 mmol /L)
8. History of drug or alcohol abuse within the 6 months prior to screening
9. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
10. History of severe or multiple allergies
11. Treatment with any other investigational drug within 3 months prior to screening
12. Progressive fatal disease
13. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dL in women and > 1.7 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
14. Pregnancy or breast feeding
15. Sexually active women of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy
16. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate beta-cell-function and beta-cell-stress as measured by the postprandial dynamics of intact proinsulin secretion after standardized test meals during standardized 12 hours inpatient treatment days;Secondary Objective: The secondary objectives are to evaluate the ratio of exogenous insulin vs. endogenous insulin, the postprandial increase in hs CRP, ADMA, glucose after treatment with insulin glargine compared with insulin detemir. Further secondary objectives are changes in fasting blood glucose, changes in 8-Point- blood glucose profiles, percentage of patients reaching the treatment goal and the insulin dosage per kg body weight to reach treatment goal. ;Primary end point(s): intact proinsulin secretion